Kornimate/medical-research-clean huggingface dataset:
effects of bariatric surgery on inspiratory metaboreflex in obese subjects

Conditions: Obesity; Metabolic Syndrome

Summary: the hypothesis of this study is that reductions in body weight could improve inspiratory muscle function attenuating the inspiratory metaboreflex in metabolically healthy obese individuals and obese individuals with metabolic syndrome.

introduction: peripheral metaboreflex activation appears to be exacerbated in obese individuals with metabolic syndrome. interestingly, bariatric surgery attenuates the peripheral metaboreflex. obese individuals have impaired inspiratory muscle function, which can be reversed by the reduction in body weight. therefore, bariatric surgery could attenuate inspiratory metaboreflex in metabolically healthy obese individuals and obese individuals with metabolic syndrome. objectives: to investigate the effects of bariatric surgery on inspiratory metaboreflex in metabolically healthy obese individuals and in obese patients with metabolic syndrome. patients and methods: a sample comprising of 15 obese subjects with metabolic syndrome, 15 obese subjects without metabolic syndrome and 15 healthy nonobese individuals. these subjects will be submitted to pulmonary function, respiratory muscle strength, inspiratory muscle resistance, exercise tolerance, quality of life, autonomic cardiovascular control and the inspiratory metaboreflex evaluation. the evaluations performed in obese patients with and without metabolic syndrome pre-surgery will be repeated 6 months after bariatric surgery.

Eligibility criteria:
obese with metabolic syndrome inclusion criteria: * body mass index (bmi)\> 35 kg / m² * diagnosis of metabolic syndrome exclusion criteria: * acute health problems in the last month (viral or bacterial infections, accidents, allergic reactions) * diseases of the nervous system or conditions that affect the understanding or participation in the study * pregnancy * type i diabetes mellitus * arterial hypertension * dyslipidemias * coronary artery disease * left ventricular dysfunction * any condition interfering with locomotion * bronchial asthma * chronic obstructive pulmonary disease * chronic neuropathies * use of drugs such as corticosteroids or bronchodilators * smokers. obese without metabolic syndrome inclusion criteria: * body mass index (bmi)\> 35 kg / m² exclusion criteria: * metabolic syndrome * acute health problems in the last month (viral or bacterial infections, accidents, allergic reactions) * diseases of the nervous system or conditions that affect the understanding or participation in the study * pregnancy * type i diabetes mellitus * arterial hypertension * dyslipidemias * coronary artery disease * left ventricular dysfunction * any condition interfering with locomotion * bronchial asthma * chronic obstructive pulmonary disease * chronic neuropathies * use of drugs such as corticosteroids or bronchodilators * smokers. healthy nonobese subjects inclusion criteria: * bmi \<25 kg / m² exclusion criteria: * non-smokers * any diagnosed disease.
joint patient and caregiver intervention for older african americans with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: this study will test the preliminary efficacy of a joint patient/informal caregiver telephone-delivered intervention that includes diabetes education; problem solving around social needs; and behavioral activation for older african americans with poorly controlled type 2 diabetes by randomizing 100 patient/caregiver dyads to the joint home intervention (n=50) and usual care (n=50) arms. the aims of the study are: aim 1: to test the preliminary efficacy of home-based, joint patient and caregiver intervention (joint home-dm-bat) on patient clinical outcomes (hemoglobin a1c, blood pressure, and ldl-cholesterol). aim 2: to test the preliminary efficacy of home-based, joint patient and caregiver intervention (joint home-dm-bat) joint home dm-bat on patient quality of life. aim 3: to test the preliminary efficacy of home-based, joint patient and caregiver intervention (joint home-dm-bat) on caregiver quality of life and caregiver burden.


Eligibility criteria:
patient inclusion criteria: 1. age ≥50 years of age; 2. self-identified as black/african american; 3. clinical diagnosis of t2dm and poorly controlled, defined as hba1c ≥8% at the screening visit; 4. able to communicate in english; and 5. has an informal caregiver (family member or close friend willing to participate in the study for 6 months. caregiver inclusion criteria: 1. willing to attend 4, one-hour sessions with the study participant; 2. willing to support the study participant for study duration (6 months); and 3. willing to complete brief baseline, 3- and 6-month assessments. patient/caregiver exclusion criteria: 1. mental confusion at screening assessment suggesting significant dementia; 2. alcohol or drug abuse/dependency at screening assessment; 3. active psychosis or acute mental disorder at screening assessment; and 4. life expectancy \<6 months at screening.
efficacy, safety and cost-effectiveness of a sequential therapy with rv4104a ointment, ciclopiroxolamine cream and ciclopirox film-forming solution compared with amorolfine nail lacquer in dermatophytic onychomycosis

Conditions: Onychomycosis

Summary: the purpose of the study is to evaluate and compare the efficacy of the sequential association rv4104a ointment followed by ciclopiroxolamine 1% cream and ciclopirox 8% film-forming solution versus amorolfine 5% nail lacquer alone in the treatment of patients with dermatophytic onychomycosis (toenail) without matrix involvement.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of distal-lateral or lateral subungual onychomycosis of one great toenail (the target nail) without matrix involvement * target nail plate showing between 25% and 60% of clinically infected area * patient must have at least 2 mm of unaffected proximal target nail area * target nail infection due exclusively to a dermatophyte (from positive fungal culture as reported by the central mycological laboratory) * female patient of childbearing potential must use an efficient contraceptive method for at least 2 months prior to screening visit * female patient of childbearing potential must have a negative urinary pregnancy test at the screening visit exclusion criteria: * patient with more than 3 affected nails * patient with onychomycosis with matrix involvement * patient with psoriasis, lichen planus or other abnormalities that could result in clinically abnormal toenail(s) * patient with moccasin-type tinea pedis * patient who has received systemic antifungal therapy or any topical antifungal therapy applied to the toenails within 3 months prior to screening visit * patient with known hypersensitivity to investigational products' ingredient(s) * patient who is currently participating or who has participated in another clinical study within 4 weeks prior to screening visit

Keywords: dermatomycoses infection mycoses nail diseases ski diseases skin diseases/infectious
ferumoxytol versus oral iron in the treatment of anemia in non-dialysis dependent chronic kidney disease patients

Conditions: Anemia

Summary: the study will evaluate the safety and efficacy of a new intravenously administered iron drug to treat anemia in patients with chronic kidney disease who are not on dialysis.

this study will evaluate the efficacy and safety of intravenous (iv) ferumoxytol as compared to oral iron in the treatment of anemia in non-dialysis dependent ckd patients. patients are randomized to receive either two doses of 510 mg of ferumoxytol within one week or 200 mg oral elemental iron daily for three weeks.

Eligibility criteria:
inclusion criteria: * male or female patients ≥ 18 years. * have chronic kidney disease per k/doqi guidelines. * no change in epo status during study. * baseline hemoglobin of ≤ 11.0 g/dl. exclusion criteria: * women who are pregnant or lactating. * received another investigational drug or device within 30 days. * recent parenteral or oral iron therapy. * patients with active gi bleeding or acute bleeding within 4 weeks. * patients that have other causes of anemia. * major surgery within 30 days or anticipated or planned major surgery during the study. * patients whose epo status changes while on study. * patients with active infections. * recent blood transfusions. * patients with any known allergies to iron products.
non attendance at scheduled appointments as a marker of mortality and hospital admission

Conditions: Appointments and Schedules; Outpatient Clinics, Hospital/Economics; Emergency Department; Hospitalization; Mortality

Summary: to evaluate the association of non attendance at scheduled appointments with visits in the emergency department, hospitalizations and mortality during one year follow up.

nonattendance at scheduled appointments at outpatient clinics is a common problem in general medical practice, representing a significant cost to the health care system, and resulting in disruption of daily work planning.nonattendance at medical appointments has consequences not only for doctors (as it requires a greater use of resources and time), but also for patients, because there may be deterioration in the quality of care, and dissatisfaction associated with delays in obtaining a new appointment

Eligibility criteria:
inclusion criteria: * over 17 years. * adults who attended, did not attend a scheduled appointment at the outpatient care system at the italian hospital of buenos aires (hiba) exclusion criteria: - the refusal to register or to the informed consent process.

Keywords: appointments and schedules outpatient clinics, hospital/economics emergency department hospitalization mortality
a study to test if tev-56286 is effective in relieving multiple system atrophy (msa): a safety and efficacy study

Conditions: Multiple System Atrophy

Summary: the primary objective of the study is to evaluate the efficacy of tev-56286 administered orally for the treatment of adult participants with multiple system atrophy (msa). a secondary objective of the study is to evaluate specific efficacy parameters of tev-56286. another secondary objective is to evaluate the safety and tolerability of tev-56286. the planned study period per participant is 56 weeks including a screening period (up to 4 weeks), a 48-week double-blind treatment period, and a follow-up visit (approximately 4 weeks after the end of the double-blind treatment period). the study duration will be approximately 27 months.

we plan to open locations in the following countries: us, israel, italy, spain, germany, france, and japan

Eligibility criteria:
inclusion criteria: * is considered to be "clinically possible" or "clinically probable" msa as determined by the gilman criteria * is able to ambulate at least 10 meters without the assistance of another person at screening; the use of assistive device (eg, cane, not walker) is allowed * is medically and psychiatrically stable, as indicated by medical and psychiatric history, as well as physical and neurological examination * females of child bearing potential (cbp) may be included only if they have a negative pregnancy test at the screening and baseline visits * females of cbp whose male partners are potentially fertile (ie, no vasectomy) must use highly effective birth control methods * males who are potentially fertile/reproductively competent (not surgically \[eg, vasectomy\] or congenitally sterile) and their female partners who are of cbp must use, together with their female partners, highly effective birth control methods * additional criteria apply; please contact the investigator for more information exclusion criteria: * has 2 or more relatives with history of msa, suggestive of an alternative diagnosis other than msa * has participated in another clinical study involving administration of an imp within 3 months or 5 half-lives (whichever is longer) of this imp prior to screening * has a history of, or acknowledges, alcohol or other substance abuse in the 12 months before screening * is a female participant who is pregnant or breastfeeding, or plans to become pregnant during the study * has a known hypersensitivity to any components of the imp * is of a vulnerable population (eg, people kept in detention or jail) * participant is using or consuming any prohibited concomitant medications within the specified exclusionary windows of this study * additional criteria apply; please contact the investigator for more information

Keywords: multiple system atrophy (msa)
systemic normothermia in intracerebral hemorrhage (ich)

Conditions: Intracerebral Hemorrhage

Summary: patients with a supratentorial intracerebral hemorrhage will be randomly assigned to either the experimental group which will keep them at a normal body temperature or the standard of care group. the investigators propose to test the hypothesis that prophylactic forced normothermia in patients with ich leads to less systemic inflammation and decreased perihematomal edema.

this is a randomized device efficacy trial. patients with a supratentorial intracerebral hemorrhage (ich) admitted to the cleveland clinic neurointensive care unit within 1 day of symptom onset and who have not experienced episodes of temperature elevation will be enrolled after consent. patients randomized to the experimental arm, will have artic sun cooling pads applied to the torso and thighs for five days. the arctic sun device will keep the body temperature at the normal range of 35.5 - 37.5 degrees celsius. patients randomized to the active comparator arm will receive a standard of care treatment at the discretion of the treating physician. patients will have hourly measurement of blood pressure, heart rate, respiratory rate, urine output, temperature (from the urinary catheter) shivering scale, and nursing neurological assessment. glasgow coma scale, nih stroke scale score (nihss), telemetry monitoring and labs will also be performed daily. the investigators will also collect demographic information about the patients (i.e. age, gender, medical risk factors) and information regarding their current disease process.

Eligibility criteria:
inclusion criteria: 1. patients with spontaneous supratentorial ich \>20 cc 2. age 18 to 85 years of age 3. consent from the patient or surrogate decision maker 4. within 24 hours of onset of ictus exclusion criteria: 1. hemorrhage secondary to trauma, arterio-venous malformation (avm), aneurysm or arterio-venous dural fistula 2. moribund state and deemed unlikely to survive until study completion (5 days) 3. patients with a don-not-resuscitate (dnr) order 4. known infection at the time of admission (elevated white blood cell count (wbc) with identified infection source). 5. evidence of a blood dyscrasia 6. pregnancy 7. renal failure (ccr \< 50 ml/min) 8. contraindications for a brain mri scan 9. infratentorial ich 10. warfarin-induced intracerebral hemorrhages not corrected to international normalized ratio (inr) \< 1.4 within 24 hours 11. episode of fever \> 38.5 degrees celsius prior to enrollment

Keywords: intracerebral hemorrhage perihematomal edema hemorrhage normothermia
annular array ultrasound in ophthalmology

Conditions: Posterior Vitreous Detachment; Diabetic Retinopathy

Summary: the objective of this research is to improve the care of ocular disease and disorders, in particular the changes in the eye associated with diabetes, by providing clinicians with dramatically improved ultrasonic images of the entire eye. the research combines advanced high-frequency, high-resolution ultrasonic annular arrays transducers with new processing techniques designed to overcome several limits that have been reached with conventional high frequency ultrasound systems. the investigators propose that diagnosis of eye diseases using annular arrays can be more effective than the conventional ultrasound images by at least 50%; i.e., that for every 2 posterior vitreous detachments detected conventionally, 3 will be detected with the annular arrays.

the goal of this study is to develop and evaluate advanced annular-array transducer technology for rapid, high-definition imaging. the study will assess high frequency ultrasound (hfu, 40 \& 20 megahertz) annular arrays in imaging posterior vitreous detachments (pvds) associated with diabetic retinopathy, the leading cause of blindness in the us working-age population according to prevent blindness america. current hfu instruments do not use linear arrays for such applications because of a variety of technical and cost reasons. instead, current hfu instruments use mechanically scanned, single-element transducers, which provide fine-resolution images over a very limited depth of field (dof). for ophthalmic applications, a shallow dof causes most ocular anatomy to be imaged with poor definition compared to the in-focus region; therefore, because only a small portion of the eye is in focus at a given time, detection and assessment of ocular conditions such as pvd are prone to inaccuracies and false-negative determinations. annular-array transducers offer a promising approach to significantly extend dof and to increase the depth range over which fine-lateral resolution is provided. the investigators will validate system performance using animal experiments and human-subject examinations. first, in vivo animal experiments will be conducted to evaluate a 40-megahertz (mhz) annular array for anterior-segment imaging and a 20-mhz annular array for posterior segment and full-globe imaging. the investigators will test the hypothesis that 20-mhz annular arrays improve detection of pvd. validation of this hypothesis will significantly improve our ability to assess disease status in diabetic retinopathy.

Eligibility criteria:
inclusion criteria: * over age 60 * people with diabetic retinopathy or posterior vitreous detachments exclusion criteria: * under age 60

Keywords: annular array ultrasound ultrasound exam posterior vitreous detachment pvd diabetic retinopathy
intra-hepatic chemotherapy in patient with non-resectable liver metastases from cholangiocarcinoma

Conditions: Cholangiocarcinoma

Summary: a phase ii trial evaluating intra-hepatic chemotherapy with oxaliplatin every second week in combination with systemic gemcitabine and capecitabine in combination with cetuximab in patient with non-resectable liver metastases from cholangiocarcinoma.


Eligibility criteria:
inclusion criteria:• informed consent * age \> 18 years * performance status 0-1; expected survival ≥ 3 months * patient with histologically or cytologically adenocarcinoma developed from cells in the gall bladder, extra- or intrahepatic bile ducts or malignant cells consistent with above mentioned and radiologic findings consistent with cholangiocarcinoma * liver metastases not suitable for surgery or other local treatment * extrahepatic disease should be excluded by pet-ct-scan. * prior treatment with chemotherapy or no progression on first line treatment * metastases \< 70 % of the liver * neutrophile granulocytes ≥ 1.5 x 109/l og thrombocytes ≥ 100 x 109/l * bilirubin \< 2.0 x unl (upper normal limit). * creatinine-clearance ≥ 30 ml/min. * inr \< 2. * intrahepatic treatment can be accomplished * the patients is approved by a multidisciplinary team exclusion criteria:• other current or prior malignant disease except adequately treated and cured carcinoma in situ of the cervix or squamous cell carcinoma of the skin. * cytotoxic or experimental treatment within a 14 days period before start of trial medication * the patient is not allowed to participate in other clinical trials. * any clinical symptoms suggesting peripheral neuropathy grade 2 * other severe medical conditions * severe cardial disease or ami \< 1 year * presence of diseases preventing oral therapy * patients with uncontrolled infection * pregnant or lactating women * women capable of childbearing not using a sufficient method of birth control * patients not able to understand the treatment or to collaborate * prior serious or unsuspected reaction after treatment with fluoropyrimidine * known prior hypersensitivity reactions to the agents * interstitial pneumonitis or pulmonary fibrosis
a randomized clinical trial on the effectiveness of novel plano spectacle lenses on myopia prevention in pre-myopic children

Conditions: Myopic Children

Summary: evaluate the efficacy, safety and wearing time compliance of novel plano spectacle lenses in delaying myopia onset in pre-myopic children and provide scientific basis for the development of myopia prevention strategies for children.

children aged 6-9 years old with pre-myopia are randomly assigned to a control group and an intervention group at a 1:1 ratio. the intervention group uses novel plano spectacle lenses for at least 8 hours a day, and the control group doesn't receive any intervention. the efficacy of novel plano spectacle lenses in delaying myopia onset in pre-myopia children is evaluated by comparing the one-year incidence of myopia onset between intervention group and control group.

Eligibility criteria:
inclusion criteria: * at the time of signing the informed consent form, the subject's age must be ≥6 years and \<10 years (6-9.99 years); * both eyes are not myopic (se\>-0.50d under cycloplegia) and at least one eye meets the pre-myopia condition ( -0.50d\< se under cycloplegia ≤+0.75d); \[spherical equivalent (se)=sph+cyl/2\] * astigmatism ≤1.00d in each eye; * difference in ser (anisometropia) between the two eyes should not exceed ≤1.50d; * unaided distance and near visual acuity of at least 0.1 logmar in each eye ; * be in good general health; * be able to actively cooperate with the intervention plan and ophthalmological examination; * normal binocular vision * at least one parent with ser ≤-3.00 d exclusion criteria: * incapable of expressing consent * all categories of persons particularly protected by law * subject in another study which might have an influence on vision or interfere with study assessment. * previous use of other prevention solutions, such as but not limited to red light therapy within 6 months, atropine and other interventions were used within 3 months; * history or presence of an ocular disease, systemic disease, strabismus or amblyopia or other binocular vision abnormalities, accommodation dysfunction, cataract and eye surgery; * those who are allergic cycloplegic drugs; * other reasons that the investigator considers inappropriate for inclusion in the study.

Keywords: pre-myopic children evaluation intervention comliance
finding the optimal location for saturation measurement during flexible bronchoscopy

Conditions: Lung Diseases; Desaturation of Blood

Summary: an observational comparison of different locations of saturation measurements during flexible bronchoscopy

the study group will include 100 patients undergoing flexible fiberoptic bronchoscopy (ffb). the patients will receive sedation with midazolam, fentanyl and propofol. all patients will receive supplemental oxygen via nasal cannula (2-4 l/min) before the beginning of the procedure. in all cases, patients will be monitored using continuous electrocardiography, pulse oximetry (on patients finger), and transcutaneous carbon dioxide and saturation (on patients earlobe), and automated noninvasive blood pressure recordings every 5 minutes. all parameters will be recorded from accepting patient to bed of procedure until 10 minutes after removal of ffb from nasopharynx. the saturation will be measured in 3 different locations (one pulse is added in other earlobe). additionally, a blood gas sample will be taken during discrepancy between different measurements. immediately after the end of procedure, the measurements from 3 different monitors will be printed, and the blood sample be taken to a gas sample machine by the investigator. desaturation value and time will be compared between the different locations. the blood arterial saturation will be compared to other measurements taken at the same time.

Eligibility criteria:
inclusion criteria: * informed consent exclusion criteria: -

Keywords: bronchoscopy saturation